Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1).

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

About this trial

The aim of this observational study is to assess the effectiveness of automatic insulin infusion in responding to changes in insulin sensitivity throughout various phases of the menstrual cycle in a cohort of reproductive-aged women with type 1 diabetes, using an advanced closed-loop system. By gaining insights into both the limitations and effectiveness of this adaptation, we aim to inform the enhancement of control algorithms and learning strategies within closed-loop systems. This research is especially vital for addressing the distinct challenges that women commonly encounter in maintaining glycemic control.

Eligibility criteria

Qualifiers

Diagnostic criteria for DM1 according to ADA

Women and men treated with the Medtronic© MinimedTM 780G advanced closed loop system.

Women presenting spontaneous regular menstrual cycles with a duration of 24 to 35 days, during the last year.

Men under 50 years old.

Disqualifiers

Gestation

Use of hormonal contraceptives (including intrauterine devices)

Institutionalization, serious or terminal illness or renal replacement therapy.

Refusal to participate in the study or to sign the informed consent

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

119 Participants
are grouped into 2 trial groups

Sponsors and collaborators